New Federal Health Initiative to Improve Cancer Therapy

Patients will Benefit from Rapid Development and Delivery of
New Cancer Treatments

The Food and Drug Administration (FDA), the National Cancer
Institute (NCI), part of the National Institutes of Health, and the
Centers for Medicare & Medicaid Services (CMS) today announced
the Oncology Biomarker Qualification Initiative (OBQI) -- an
agreement to collaborate on improving the development of cancer
therapies and the outcomes for cancer patients through biomarker
development and evaluation.

Biomarkers are biologic indicators of disease or therapeutic
effects, which can be measured through dynamic imaging tests, as
well as tests on blood, tissue and other biologic samples. This
initiative is the first time these three Department of Health and
Human Services (HHS) agencies have focused together on biomarkers
as a way of speeding the development and evaluation of cancer
therapies.

"We are excited about this effort to speed the development and
delivery of new cancer treatments for patients," said Secretary of
Health and Human Services Mike Leavitt. "By bringing together the
scientific, regulatory and delivery expertise of these three
agencies, we can bring targeted, more personalized cancer
diagnostics, treatments and preventions to patients more
rapidly."

The collaboration will develop scientific understanding of how
biomarkers can be used to assess the impact of therapies and better
match therapies to patients. For instance, OBQI will address
questions such as how particular biomarkers can be used to:

Assess after one or two treatments if a patient's tumor is
responding to treatment

Determine more definitively if a tumor is dying, even if it is
not shrinking

Identify which cancer patients are at high risk of their tumor
coming back after therapy

Determine if a patient's tumor is likely to respond at all to a
specific treatment

The goal of OBQI is to validate particular biomarkers so that
they can be used to evaluate new, promising technologies in a
manner that will shorten clinical trials, reduce the time and
resources spent during the drug development process, improve the
linkage between drug approval and drug coverage, and increase the
safety and appropriateness of drug choices for cancer patients.

"Almost four years ago, NIH set out to create a "roadmap" for
21st century medical research. Programs like OBQI will be central
to that vision, not only because they will lead to vital
discoveries about the biology of disease, but because they will be
models for scientific collaboration," said NIH Director Elias A.
Zerhouni, M.D.

"An enhanced understanding of clinical biomarkers will help make
the development of diagnostics and treatments more targeted, one of
our most pressing goals under the Critical Path Initiative, FDA's
program to modernize the medical product development process," said
FDA Acting Commissioner of Food and Drugs Andrew C. von Eschenbach,
M.D. "We believe partnerships that help us standardize the use of
new technologies are essential to refining the drug development
process, so we can bring personalized medicines to patients more
quickly and ultimately improve outcomes."

Under the OBQI, biomarker research will be focused in four key
areas: standardizing and evaluating imaging technologies to see in
more detail how treatments are working, developing scientific bases
for diagnostic assays to enable personalized treatments,
instituting new trial designs to utilize biomarkers, and pooling
data to ensure that key lessons are shared from one trial to
another. By working with academic and industry scientists, as well
as professional organizations, the OBQI teams can foster the
development of key information on biomarkers through clinical
trials.

"By identifying biomarkers for specific cancers and clinically
evaluating them, researchers will have an evidence base for their
use in targeted drug development and to determine which therapies
are likely to work for patients before treatment selection," said
NCI Deputy Director Anna D. Barker, Ph.D. "Rather than waiting
weeks to months to determine if a specific drug works for a
patient, biomarkers could be used to monitor real-time treatment
responses."

The first OBQI project to be implemented will serve to validate
and standardize the use of Fluorodeoxyglucose - Positron Emission
Tomography (FDG-PET) scanning. PET scans are used to characterize
biochemical changes in a cancer. Under the collaboration,
researchers will use FDG-PET imaging technology in trials of
patients being treated for non-Hodgkin's lymphoma, to determine if
FDG-PET is a predictor of tumor response. Data resulting from this
type of evidence-based study will help both FDA and CMS work with
drug developers based on a common understanding of the roles of
these types of assessments.

"There are many steps between a novel scientific idea with
tremendous promise and a new drug reliably benefiting patients,"
said CMS Administrator Mark B. McClellan, M.D., Ph.D. "This
collaboration will produce evidence that will help people with
Medicare and Medicaid get better care more quickly, as a result of
better-targeted treatment decisions for cancer patients."

Over the next several months, the OBQI team will design a number
of initiatives to identify and clinically qualify other cancer
biomarkers. The new initiatives will bring together scientists from
many sources and address agency priorities identified through FDA's
Critical Path and NIH's Roadmap Initiatives. The OBQI also
represents the work of the NCI-FDA Interagency Oncology Task Force
(IOTF). The IOTF is a collaboration between NCI and FDA to enhance
the efficiency of clinical research and the scientific evaluation
of new cancer treatments. The two agencies, along with CMS, share
knowledge and resources to facilitate the development of new cancer
drugs and diagnostics and speed their delivery to patients as
safely and as cost-effectively as possible.

FDA Critical Path

Critical Path is the FDA's premier initiative to identify and
prioritize the most pressing medical product development problems
and the greatest opportunities for rapid improvement in public
health benefits. Its primary purpose is to ensure that basic
scientific discoveries translate more rapidly into new and better
medical treatments by creating new tools to find answers about how
the safety and effectiveness of new medical products can be
demonstrated in faster timeframes with more certainty and at lower
costs.

The NIH Roadmap

The NIH Roadmap is a series of new initiatives designed to
pursue major opportunities and gaps in biomedical research that no
single NIH institute could tackle alone, but which the agency as a
whole can address to make the biggest impact possible on the
progress of medical research, and to catalyze changes that will
serve to transform new scientific knowledge into tangible benefits
for public health. Additional information about the NIH Roadmap can
be found at its Web site, www.nihroadmap.nih.gov.

For information about the Food and Drug Administration, please
visit www.fda.gov.
For additional information about the National Cancer Institute,
please visit www.cancer.gov.
For information about the Centers for Medicare & Medicaid
Services, please visit www.cms.hhs.gov.